JP2012526140A5 - - Google Patents
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- JP2012526140A5 JP2012526140A5 JP2012509968A JP2012509968A JP2012526140A5 JP 2012526140 A5 JP2012526140 A5 JP 2012526140A5 JP 2012509968 A JP2012509968 A JP 2012509968A JP 2012509968 A JP2012509968 A JP 2012509968A JP 2012526140 A5 JP2012526140 A5 JP 2012526140A5
- Authority
- JP
- Japan
- Prior art keywords
- package
- storage
- less
- pharmaceutical product
- storage method
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 239000000825 pharmaceutical preparation Substances 0.000 claims description 34
- 238000009472 formulation Methods 0.000 claims description 25
- 239000000203 mixture Substances 0.000 claims description 25
- 239000007787 solid Substances 0.000 claims description 23
- 239000002274 desiccant Substances 0.000 claims description 20
- 239000003795 chemical substances by application Substances 0.000 claims description 16
- 238000002360 preparation method Methods 0.000 claims description 16
- 229920002774 Maltodextrin Polymers 0.000 claims description 8
- 239000005913 Maltodextrin Substances 0.000 claims description 8
- HEBKCHPVOIAQTA-SCDXWVJYSA-N Xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims description 8
- 229960002675 Xylitol Drugs 0.000 claims description 8
- 229940035034 maltodextrin Drugs 0.000 claims description 8
- 239000000546 pharmaceutic aid Substances 0.000 claims description 8
- 238000004321 preservation Methods 0.000 claims description 8
- 235000010447 xylitol Nutrition 0.000 claims description 8
- 239000000811 xylitol Substances 0.000 claims description 8
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 6
- 238000009512 pharmaceutical packaging Methods 0.000 claims description 4
- RHWRWEUCEXUUAV-ZSESPEEFSA-N 2-[[(1R,2R,3aS,9aS)-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta[g]naphthalen-5-yl]oxy]acetic acid;2-(2-hydroxyethylamino)ethanol Chemical group OCCNCCO.C1=CC=C(OCC(O)=O)C2=C1C[C@@H]1[C@@H](CC[C@@H](O)CCCCC)[C@H](O)C[C@@H]1C2 RHWRWEUCEXUUAV-ZSESPEEFSA-N 0.000 claims 4
- 239000003814 drug Substances 0.000 claims 1
- 238000004806 packaging method and process Methods 0.000 claims 1
- 229960005032 Treprostinil Drugs 0.000 description 16
- PAJMKGZZBBTTOY-ZFORQUDYSA-N treprostinil Chemical group C1=CC=C(OCC(O)=O)C2=C1C[C@@H]1[C@@H](CC[C@@H](O)CCCCC)[C@H](O)C[C@@H]1C2 PAJMKGZZBBTTOY-ZFORQUDYSA-N 0.000 description 16
- 150000003839 salts Chemical class 0.000 description 12
- 239000011780 sodium chloride Substances 0.000 description 12
- ZBCBWPMODOFKDW-UHFFFAOYSA-N Diethanolamine Chemical compound OCCNCCO ZBCBWPMODOFKDW-UHFFFAOYSA-N 0.000 description 4
- NBIIXXVUZAFLBC-UHFFFAOYSA-K [O-]P([O-])([O-])=O Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 4
- 150000001413 amino acids Chemical class 0.000 description 4
- 125000001797 benzyl group Chemical group [H]C1=C([H])C([H])=C(C([H])=C1[H])C([H])([H])* 0.000 description 4
- 150000002148 esters Chemical class 0.000 description 4
- -1 glycolamide ester Chemical class 0.000 description 4
- 239000010452 phosphate Substances 0.000 description 4
- 102000004169 proteins and genes Human genes 0.000 description 4
- 108090000623 proteins and genes Proteins 0.000 description 4
- 0 CCCCC[C@](*)CC[C@]1[C@](*)CC(C2)C1Cc1c2c(*)ccc1 Chemical compound CCCCC[C@](*)CC[C@]1[C@](*)CC(C2)C1Cc1c2c(*)ccc1 0.000 description 1
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US17626809P | 2009-05-07 | 2009-05-07 | |
US61/176,268 | 2009-05-07 | ||
PCT/US2010/033852 WO2010129757A1 (en) | 2009-05-07 | 2010-05-06 | Solid formulations of prostacyclin analogs |
Publications (3)
Publication Number | Publication Date |
---|---|
JP2012526140A JP2012526140A (ja) | 2012-10-25 |
JP2012526140A5 true JP2012526140A5 (zh) | 2014-05-01 |
JP5649645B2 JP5649645B2 (ja) | 2015-01-07 |
Family
ID=43050464
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2012509968A Active JP5649645B2 (ja) | 2009-05-07 | 2010-05-06 | プロスタサイクリンアナログの固形製剤 |
Country Status (7)
Country | Link |
---|---|
US (1) | US8349892B2 (zh) |
EP (1) | EP2427054A4 (zh) |
JP (1) | JP5649645B2 (zh) |
KR (1) | KR101544246B1 (zh) |
CN (1) | CN102421288B (zh) |
CA (1) | CA2760499C (zh) |
WO (1) | WO2010129757A1 (zh) |
Families Citing this family (30)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CA2959852A1 (en) | 2003-05-22 | 2005-01-27 | United Therapeutics Corporation | Compounds and methods for delivery of prostacyclin analogs |
JP2007532663A (ja) * | 2004-04-12 | 2007-11-15 | ユナイテッド セラピューティクス インコーポレイテッド | ニューロパシー性の糖尿病性足潰瘍を治療するためのトレプロスチニルの使用 |
WO2007134292A2 (en) | 2006-05-15 | 2007-11-22 | United Therapeutics Corporation | Treprostinil administration using a metered dose inhaler |
DE102006026786A1 (de) | 2006-06-07 | 2007-12-13 | Joachim Kern | Dosierinhalator |
EP2252570B1 (en) | 2007-12-17 | 2017-04-05 | United Therapeutics Corporation | An improved process to prepare treprostinil, the active ingredient in remodulin ® |
KR20160132501A (ko) | 2010-03-15 | 2016-11-18 | 유나이티드 세러퓨틱스 코오포레이션 | 폐고혈압의 치료 |
EP2576492B1 (en) | 2010-06-03 | 2017-09-20 | United Therapeutics Corporation | Treprostinil production |
US20120004307A1 (en) * | 2010-06-15 | 2012-01-05 | United Therapeutics Corporation | Oral treatment of digital ischemic lesions |
US20130345471A1 (en) | 2011-03-02 | 2013-12-26 | United Therapeutics Corporation | Synthesis of intermediate for treprostinil production |
CN103193627B (zh) * | 2012-01-10 | 2016-04-20 | 上海天伟生物制药有限公司 | 一种前列腺素类似物的晶型及其制备方法和用途 |
US9505737B2 (en) | 2013-01-11 | 2016-11-29 | Corsair Pharma, Inc. | Treprostinil derivative compounds and methods of using same |
JP6542128B2 (ja) | 2013-01-11 | 2019-07-10 | コルセア ファーマ インコーポレイテッド | トレプロスチニルのプロドラッグ |
US9822057B2 (en) | 2013-03-14 | 2017-11-21 | United Therapeutics Corporation | Solid forms of treprostinil |
KR20150128903A (ko) | 2013-03-15 | 2015-11-18 | 유나이티드 세러퓨틱스 코오포레이션 | 트레프로스티닐의 염 |
JP6263604B2 (ja) | 2013-03-25 | 2018-01-17 | ユナイテッド セラピューティクス コーポレイション | チオールリンカーを持つ、ペグ化型のプロスタサイクリン化合物の製造方法 |
EA031604B1 (ru) | 2013-10-25 | 2019-01-31 | Инсмед Инкорпорейтед | Трепростинильные соединения, композиции и способы их использования |
KR102512890B1 (ko) | 2014-06-13 | 2023-03-21 | 유나이티드 세러퓨틱스 코오포레이션 | 트레프로스티닐 제제 |
KR101890080B1 (ko) | 2014-10-20 | 2018-09-20 | 유나이티드 쎄러퓨틱스 코포레이션 | 프로스타시클린 유도체 제조를 위한 중간체의 합성 |
EP3221291B1 (en) | 2014-11-18 | 2021-03-31 | Insmed Incorporated | Methods of manufacturing treprostinil and treprostinil derivative prodrugs |
US9643911B2 (en) | 2015-06-17 | 2017-05-09 | Corsair Pharma, Inc. | Treprostinil derivatives and compositions and uses thereof |
US9394227B1 (en) | 2015-06-17 | 2016-07-19 | Corsair Pharma, Inc. | Treprostinil derivatives and compositions and uses thereof |
KR102541885B1 (ko) | 2016-09-26 | 2023-06-12 | 유나이티드 쎄러퓨틱스 코포레이션 | 트레프로스티닐 프로드럭 |
US10799653B2 (en) | 2017-01-09 | 2020-10-13 | United Therapeutics Corporation | Aerosol delivery device and method for manufacturing and operating the same |
JP7455144B2 (ja) | 2019-04-29 | 2024-03-25 | インスメッド インコーポレイテッド | トレプロスチニルプロドラッグの乾燥粉末組成物およびその使用方法 |
WO2021041320A1 (en) | 2019-08-23 | 2021-03-04 | United Therapeutics Corporation | Treprostinil prodrugs |
AU2021255621A1 (en) | 2020-04-17 | 2022-10-20 | United Therapeutics Corporation | Treprostinil for use in the treatment of intersitial lung disease |
WO2021252446A1 (en) | 2020-06-09 | 2021-12-16 | United Therapeutics Corporation | Fumaryl diketopiperidine prodrugs of treprostinil |
JP2023553989A (ja) | 2020-12-14 | 2023-12-26 | ユナイテッド セラピューティクス コーポレイション | トレプロスチニルプロドラッグで疾患を治療する方法 |
KR20240012354A (ko) | 2021-03-03 | 2024-01-29 | 유나이티드 쎄러퓨틱스 코포레이션 | (e)-3,6-비스[4-(n-카보닐-2-프로페닐)아미도부틸]-2,5-디케토피페라진(fdkp)을 추가로 포함하는, 트레프로스티닐 및 이의 프로드러그의 건조 분말 조성물 |
US20230263807A1 (en) | 2022-02-08 | 2023-08-24 | United Therapeutics Corporation | Treprostinil iloprost combination therapy |
Family Cites Families (24)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4306075A (en) * | 1980-03-28 | 1981-12-15 | The Upjohn Company | Composition and process |
GB8814438D0 (en) * | 1988-06-17 | 1988-07-20 | Wellcome Found | Compounds for use in medicine |
GB9011588D0 (en) * | 1990-05-24 | 1990-07-11 | Wellcome Found | Prostaglandin analogues for use in medicine |
US6441245B1 (en) * | 1997-10-24 | 2002-08-27 | United Therapeutics Corporation | Process for stereoselective synthesis of prostacyclin derivatives |
CA2312729C (en) * | 1997-11-14 | 2006-05-23 | United Therapeutics Corporation | Use of 9-deoxy-2', 9-.alpha.-methano-3- oxa-4,5,6- trinor-3, 7-(1',3'-interphenylene) -13,14-dihydro- prostaglandin f1 to treat peripheral vascular disease |
US6521212B1 (en) * | 1999-03-18 | 2003-02-18 | United Therapeutics Corporation | Method for treating peripheral vascular disease by administering benzindene prostaglandins by inhalation |
US6700025B2 (en) * | 2001-01-05 | 2004-03-02 | United Therapeutics Corporation | Process for stereoselective synthesis of prostacyclin derivatives |
US6803386B2 (en) * | 2002-01-16 | 2004-10-12 | United Therapeutics Corporation | Prostacyclin derivative containing compositions and methods of using the same for the treatment of cancer |
EP1471049A4 (en) * | 2002-01-30 | 2006-08-16 | Kissei Pharmaceutical | NEW THYROIDIAN HORMONE RECEPTOR LIGAND, MEDICINAL PREPARATIONS CONTAINING THE SAME AND USE THEREOF |
CA2959852A1 (en) | 2003-05-22 | 2005-01-27 | United Therapeutics Corporation | Compounds and methods for delivery of prostacyclin analogs |
US20040265238A1 (en) * | 2003-06-27 | 2004-12-30 | Imtiaz Chaudry | Inhalable formulations for treating pulmonary hypertension and methods of using same |
US20050101608A1 (en) * | 2003-09-24 | 2005-05-12 | Santel Donald J. | Iloprost in combination therapies for the treatment of pulmonary arterial hypertension |
DE602004022982D1 (de) * | 2003-12-16 | 2009-10-15 | United Therapeutics Corp | Verwendung von treprostinil zur verbesserung der nierenfunktion |
DE602004028155D1 (de) * | 2003-12-16 | 2010-08-26 | United Therapeutics Corp | Verwendung von treprostinil zur behandlung von ischämischen läsionen |
JP2007532663A (ja) * | 2004-04-12 | 2007-11-15 | ユナイテッド セラピューティクス インコーポレイテッド | ニューロパシー性の糖尿病性足潰瘍を治療するためのトレプロスチニルの使用 |
EP1856110B1 (en) * | 2005-02-22 | 2011-06-22 | Pfizer Inc. | Oxyindole derivatives as 5ht4 receptor agonists |
US20060222792A1 (en) * | 2006-04-21 | 2006-10-05 | Chemagis Ltd. | Temozolomide storage system |
US8747897B2 (en) * | 2006-04-27 | 2014-06-10 | Supernus Pharmaceuticals, Inc. | Osmotic drug delivery system |
WO2007134292A2 (en) * | 2006-05-15 | 2007-11-22 | United Therapeutics Corporation | Treprostinil administration using a metered dose inhaler |
US20090281129A1 (en) * | 2006-05-15 | 2009-11-12 | Senex Biotechnology, Inc. | Cdki pathway inhibitors and uses thereof |
KR20090101276A (ko) * | 2006-12-21 | 2009-09-24 | 콘서트 파마슈티컬즈, 인크. | 프로스타시클린 유도체 |
EP2120961A1 (en) * | 2007-02-09 | 2009-11-25 | United Therapeutics Corporation | Treprostinil treatment for interstitial lung disease and asthma |
MX2009008828A (es) * | 2007-02-20 | 2009-12-14 | Eurand Pharmaceuticals Ltd | Composiciones de enzimas digestivas estables. |
EP2252570B1 (en) * | 2007-12-17 | 2017-04-05 | United Therapeutics Corporation | An improved process to prepare treprostinil, the active ingredient in remodulin ® |
-
2010
- 2010-05-06 WO PCT/US2010/033852 patent/WO2010129757A1/en active Application Filing
- 2010-05-06 CA CA2760499A patent/CA2760499C/en active Active
- 2010-05-06 US US12/775,102 patent/US8349892B2/en active Active
- 2010-05-06 EP EP10772819.8A patent/EP2427054A4/en not_active Withdrawn
- 2010-05-06 CN CN201080019951.3A patent/CN102421288B/zh active Active
- 2010-05-06 JP JP2012509968A patent/JP5649645B2/ja active Active
- 2010-05-06 KR KR1020117028834A patent/KR101544246B1/ko active IP Right Grant
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